Intellifuse Administration and Intellifuse Blood Administration Sets

About This 510(k) Submission

K192375 is an FDA 510(k) clearance for the Intellifuse Administration and Intellifuse Blood Administration Sets, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 18, 2020, 385 days after receiving the submission on August 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.